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Archive for Politics and Regulation

What do we do about politicians and physicians who promote antivaccine misinformation?

Given the ongoing (and increasing) measles outbreak linked initially to Disneyland, it’s hard for me not to revisit the topic from time to time. This time around, there are two issues I wish to discuss, one political and one that is a combination of medical and political. After all, it was just one week ago when New Jersey Governor Chris Christie stepped in it by advocating parental choice in vaccines, as if parents don’t already have a choice. He rapidly had to walk it back, and his ill-considered remarks were almost certainly not evidence that he is antivaccine. They are, however, evidence that he doesn’t understand that we do not have “forced vaccination” in this country (we have school vaccine mandates). Parents already have choice in 48 states, given that only two states (Mississippi and West Virginia) do not allow belief-based non-medical exemptions, be they religious exemptions, personal belief-exemptions, or both, to school vaccine mandates. It also came out that in 2009 while running for Governor, Christie met with Louise Kuo Habakus (who is antivaccine) and the NJ Coalition for Vaccine Choice, a very vocal NJ antivaccine coalition whose member organization list reads like a who’s who of the national antivaccine movement and includes Life Health Choices, the antivaccine organization founded by Habakus. He even wrote a letter promising that as governor he would stand with them in “their fight for greater parental involvement in vaccination decisions that affect their children.”

It’s also evidence that vaccine mandates are becoming even more politicized. Indeed, Senator Rand Paul, on the very same day, provided more such evidence when he claimed on a conservative talk radio show that he’s seen children with severe neurological problems after vaccination, the implication being that he believed these children’s problems were linked to vaccination. Later, in a testy exchange with a CNBC reporter, who asked him whether he had really said that he thought vaccines should be voluntary, Paul sarcastically replied, “I guess being for freedom would be unusual.” Later in the exchange, after repeating the same antivaccine talking points that he had related earlier in the day, he said, “The state doesn’t own the children. Parents own the children, and it is an issue of freedom.” You get the idea. He, too, ultimately had to back off a bit, famously showing himself getting vaccinated for hepatitis A, but given that Paul has had a long history of making similar comments, this was almost certainly strategic.
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Posted in: Politics and Regulation, Public Health, Religion, Vaccines

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Washington bills: Christian Science no longer an excuse for denying medical care

seal-of-washington

All states try to protect children from neglect, abandonment and mistreatment, such as deprivation of clothing, shelter, food and medical care. This includes civil laws which permit the removal of a child from the home and other protective interventions. Criminal laws protect children as well by, for example, making nonsupport a misdemeanor or criminal neglect a felony.

Washington State law prohibits criminal mistreatment of children and other vulnerable persons, such as the frail elderly, by their caregivers. Criminal mistreatment is defined as the “deprivation of the basic necessities of life:”

food, water, shelter, clothing, and medically necessary health care, including but not limited to health-related treatment or activities, hygiene, oxygen, and medication.

Mistreatment can be either a misdemeanor or felony, depending on whether the defendant’s conduct amounts to criminal negligence or recklessness and the degree of harm caused to the victim. Punishment ranges from 90 days in jail and a $1,000 fine to 10 years in jail and a $20,000 fine.

Unfortunately, parents and other caregivers in Washington have what amounts to an almost literal “get out of jail free” card if the mistreatment takes the form of “treatment” by “duly accredited” Christian Science practitioner: (more…)

Posted in: Faith Healing & Spirituality, Legal, Politics and Regulation, Religion

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Selling complementary and alternative medicine: An business ethics perspective

I joined Professor Chris MacDonald at Ryerson University earlier this week to participate in Ryerson’s business ethics speaker series. The topic was CAM:

Is it ethical to market complementary and alternative medicines? Complementary and alternative medicines (CAM) are medical products and services outside the mainstream of medical practice. But they are not just medicines (or supposed medicines) offered and provided for the prevention and treatment of illness. They are also products and services – things offered for sale in the marketplace. Most discussion of the ethics of CAM has focused on bioethical issues – issues having to do with therapeutic value, and the relationship between patients and those purveyors of CAM. This presentation — by a philosopher and a pharmacist — aims instead to consider CAM from the perspective of commercial ethics. That is, we consider the ethics not of prescribing or administering CAM (activities most closely associated with health professionals) but the ethics of selling CAM.

If it’s not embedded above, you can watch the whole presentation on CAM and business ethics with this link.

It was great to see so many public members attend and participate. There was an extended Q&A afterwards, with some very thoughtful audience questions. Outside of blogs like this, and those of CAM critics like Edzard Ernst, the practical ethics of CAM provision are rarely discussed.  Watch for more on this topic in the future.

 

Posted in: Announcements, Homeopathy, Medical Ethics, Politics and Regulation

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Stem cell clinics and unapproved, for-profit human experimentation

Editor’s note: I met Dr. Paul Knoepfler online in the wake of my two posts on Gordie Howe and his stem cell treatment for stroke. I was impressed by his posts on the topic and what I saw at his own blog. Given that he’s a stem cell researcher, I wanted him to write a post on stem cell clinics like the one that treated Gordie Howe, and, I’m happy to say, he accepted my invitation and agreed to write this post. I hope to persuade him to write more for us in the future, even though he has his own blog.


When I started blogging in 2010 the stem cell arena was a very different place.

Back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding to continue. The stem cell debate of today, which in its own way is just as fierce as the old one, is focused on how best to regulate the clinical translation and commercialization of innovative stem cell technologies.

The stakes in this new stem cell battle on the regulatory front are very high both for the stem cell field and for patients. Too little regulation could lead to harm to patients and damage to the stem cell field at a crucial juncture in its history, while too much regulation could stifle stem cell and regenerative medicine innovations.

Stem cell clinics should be better-regulated than a Starbucks

Stem cell clinics should be better-regulated than a Starbucks

The goal of stem cell advocates, including myself, is to find a regulatory sweet spot where science-based, innovative stem cell medicine can advance expeditiously. On the other side we have largely physicians and lawyers along with some patients arguing for drastically-reduced regulation and acceleration of for-profit stem cell interventions to patients, even without concrete data supporting safety or efficacy.

The latter group is a key part of a rapidly-proliferating stem cell clinic industry in the US. It consists of for-profit stem cell clinics that collectively have already conducted stem cell transplants on potentially thousands of patients without federal regulatory approval. These clinics have in effect thrown down the gauntlet to the US Food and Drug Administration (FDA) with their use of non-FDA approved stem cell products on patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Science and the Media

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New FDA regulatory role threatens bogus diagnostic tests

lab test
The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it focused on commercial tests kits, which are broadly marketed to laboratories or the public. These tests had to undergo the same pre-market approval process as other medical devices regulated by the FDA, including, in some cases, clinical studies demonstrating that the device is safe and effective for its intended use.

Historically, LDTs were developed by hospitals, researchers and academic medical centers for their own use. That is no longer true. In the past 15 years or so, there has been an explosion in the use of LDTs by commercial labs and biotechnology companies. The FDA now estimates that there are about 11,000 LDTs offered by 2,000 laboratories. One estimate is that the results of clinical lab tests (although not exclusively LDTs) influence 70% of health care decisions. (See the Congressional Research Service Report’s exhaustive analysis of FDA regulation of IVDs and inclusion of LDTs for more on the history and current use of LDTs.)

Do you have any idea whether the IVDs that have poked around in your blood or tissues are FDA-approved or unapproved LDTs? (Does your physician?) Do you know what evidence (if any) there is standing behind these tests? No? Me either. That’s because there is no requirement that anyone give you this information. (more…)

Posted in: Diagnostic tests & procedures, Legal, Medical devices, Naturopathy, Politics and Regulation

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Smoking Cessation and the Affordable Care Act

A young child and a chicken — neither of whom should smoke.

A young child and a chicken — neither of whom should smoke.

Smoking is the leading preventable cause of death. Each year it kills more than 5 million people around the world, 480,000 in the US alone. And for every person who dies, about 30 more have serious illnesses caused by smoking. On average, smokers die 10 years earlier than nonsmokers. Anyone who is concerned about preventive medicine must consider smoking cessation a priority. Fortunately, the Affordable Care Act (ACA) has taken a step in the right direction.

The ACA’s provisions

The Affordable Care Act requires health plans and health insurance to cover tobacco-use counseling and interventions without cost sharing or prior authorization. It requires screening of all patients for tobacco use and covering at least two attempts to quit each year. For each quit attempt, it authorizes four tobacco-cessation counseling sessions, each at least ten minutes long (including telephone, group, and individual counseling) and any FDA-approved tobacco-cessation medications (whether prescription or over-the-counter) for a 90-day treatment regimen when prescribed by a health care provider. In a separate provision, it requires that states not exclude FDA-approved cessation medications from existing Medicaid programs. These provisions should encourage providers and patients to increase their smoking cessation efforts. (more…)

Posted in: Politics and Regulation, Public Health

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2014: Chiropractors, naturopaths and acupuncturists lose in state legislatures

I am happy to report some good news: chiropractors, naturopaths, acupuncturists and assorted other practitioners of pseudo-medicine didn’t fare too well in the 2013-2014 state legislative sessions.

We’ve been following their legislative efforts all year over at the Society for Science-Based Medicine. Some state legislatures meet in yearly sessions. At the end of the year, pending bills die with the session. Some meet only every other year. Others meet in two-year sessions and, in some of these, legislation introduced in one year carries over to the next year. All states with two-year sessions ended these sessions at the close of 2014, except New Jersey and Virginia. If you want to see how your state operates, several websites can help you: MultiState Associates, National Conference of State Legislatures and StateScape.

Chiropractors

Chiropractors are already licensed in all 50 states and all of their practice acts permit the detection and correction of the non-existent subluxation. Having achieved that goal, the focus of chiropractic legislative efforts is to expand their scope of practice (the holy grail, for some, being primary care physician status), turf protection and mandates requiring insurance reimbursement or their inclusion in various activities, such as sports physicals, concussion treatment, and scoliosis detection programs.

The most interesting chiropractic bill, one from Oklahoma, didn’t fall into any of those categories:

Chiropractic physicians in this state shall obtain informed, written consent from a patient prior to performing any procedure that involves treatment of the patient’s cervical spine and such informed consent shall include the risks and possible side effects of such treatment including the risk of chiropractic stroke.

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Posted in: Acupuncture, Chiropractic, Diagnostic tests & procedures, Herbs & Supplements, Homeopathy, Legal, Naturopathy, Politics and Regulation, Traditional Chinese Medicine

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SFSBM Report upsets naturopaths. We’re fine with that.

Sisyphus
The Maryland Naturopathic Doctors Association is not pleased with the Society for Science-Based Medicine. Not at all.

That is a good thing, for several reasons. It demonstrates the importance of stopping naturopathic licensing (and practice expansion) legislation in the state legislatures. It shows how they handle legitimate criticism of their practices. And it is a lesson in their modus operandi of obfuscating the facts with platitudinous- but-vague pronouncements about their education, training and practice, pronouncements that wither under criticism.

Why is the MNDA so upset with the SFSBM?

We’ll answer that question soon, but some background first. The Maryland Legislature passed a naturopathic licensing bill this year. Fortunately, as I’ve written, the Legislature didn’t give naturopaths everything they wanted, such as the right to prescribe real drugs. That’s not stopping them from coming back to the Legislature to revisit the issue. According to naturopathic school Bastyr’s website:

The [Maryland] law limits some parts of the naturopathic scope of practice — such as intravenous (IV) therapies and prescription drugs — that the state association will work to secure in the future.

Instead of giving naturopaths their own regulatory board, like they wanted, the Legislature put them under the authority of the Maryland Board of Physicians. The Legislature created a Naturopathic Advisory Committee to recommend regulations governing naturopathic practice to the Board. The Maryland Naturopathic Doctors Association (MNDA) states, incorrectly, on its website that the Committee will actually be promulgating the regulations and implementing the law. The statute is quite clear that this is not the case. Those duties are entirely within the jurisdiction of the Board. (more…)

Posted in: Diagnostic tests & procedures, Homeopathy, Legal, Naturopathy, Politics and Regulation, Vaccines

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Ontario fails to protect the life of a First Nations girl with cancer

First Nations

A few weeks ago, Steve Novella invited me on his podcast, The Skeptics’ Guide to the Universe, to discuss a cancer case that has been in the news for several months now. The case was about an 11-year-old girl with leukemia who is a member of Canada’s largest aboriginal community. Steve wrote about this case nearly a month ago. Basically, the girl’s parents are fighting for the right to use “natural healing” on their daughter after they had stopped her chemotherapy in August because of side effects. It is a profoundly disturbing case, just as all the other cases I’ve discussed in which children’s lives are sacrificed at the altar of belief in alternative medicine, but this one has a twist that I don’t recall having dealt with before: The girl’s status as part of the First Nations. Sadly, on Friday, Ontario Court Justice Gethin Edward has ruled that the parents can let their daughter die.

The First Nations consist of various Aboriginal peoples in Canada who are neither Inuit nor Métis. There are currently more than 630 recognized First Nations governments or bands in Canada, half of which are located in Ontario and British Columbia. This girl lives in Ontario, which is basically just next door to Detroit, just across the Detroit River. Unlike previous cases of minors who refuse chemotherapy or whose parents refuse chemotherapy for them that I’ve discussed, such as Sarah Hershberger, an Amish girl whose parents were taken to court by authorities in Medina County, Ohio at the behest of Akron General Hospital, where she had been treated because they stopped her chemotherapy for lymphoblastic lymphoma in favor of “natural healing,” or Daniel Hauser, a 13-year-old boy from Minnesota with Hodgkin’s lymphoma whose parents, in particular his mother, refused chemotherapy after starting his chemotherapy and suffering side effects, there’s very little information about this girl because of Canadian privacy laws. I do not know her name. I do not know anything about her case except that she has acute lymphoblastic leukemia, that she started treatment but her parents withdrew her because of side effects.
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Posted in: Cancer, Faith Healing & Spirituality, Politics and Regulation, Religion

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Political Science: Chronic Lyme Disease

Tick

New York may soon join a handful of other states who reject science-based guidelines for the treatment of Lyme disease in favor of ideological guidelines based on the vociferous lobbying of patients and “Lyme literate” health care providers. Ignoring science is an unfortunate but well-known legislative phenomenon. I’ve discussed it a number of times on SBM, in the form of Legislative Alchemy, the process by which credulous state legislators turn practitioners of pseudoscience into state-licensed health care professionals, such as naturopaths, chiropractors, homeopaths and acupuncturists.

Lyme disease is an infectious disease transmitted by a tick bite. Its symptoms are a rash, fever, headache and fatigue, although not all symptoms may appear. According to the Infectious Diseases Society of America (IDSA):

Lyme disease is diagnosed by medical history, physical exam, and sometimes a blood test. It may take four to six weeks for the human immune system to make antibodies against Borrelia burgdorferi and therefore show up in a positive blood test. That is why patients with the Lyme rash usually have a negative blood test and diagnosis is based on the characteristic appearance of the rash. Patients with other clinical manifestations such as Lyme arthritis will usually have a blood test. Anyone who has symptoms for longer than six weeks and who has never been treated with antibiotics is unlikely to have Lyme disease if the blood test is negative.

Treatment with antibiotics usually eliminates the symptoms, but delayed treatment can result in more serious problems. (more…)

Posted in: Critical Thinking, Health Fraud, Legal, Politics and Regulation

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